Republic of the Philippines

Department of Health
FOOD AND DRUG ADMINISTRATION

List of Approved PCR Based Test Kits for Commercial Use

as of 17 AUGUST 2020

NO. PRODUCT NAME MANUFACTURER

1 Nucleic acid detection kit for 2019 ncov Shanghai GenoeDx Biotech Co., LTD- Shanghai , China.

2 A*STAR FORTITUDE KIT 2.0 (COVID-19 ACCELERATE TECHNOLOGIES PTE. LTD.- Chromos
Real-Time RT-PCR TEST) Building, Singapore

3 Novel coronavirus 2019-ncov nucleic acid Beijing Applied Biological Technologies Co., Ltd-
detection kit (fluorescence PCR Changping District 102206 Beijing P.R
method)-

4 AllplexTM 2019-nCoV Assay Seegene Inc. -Seoul, Republic of Korea

5 SOLGENT DiaPlexQ™ Novel Coronavirus Solgent Co., Ltd-3F, 32, Techno 6-ro, Yuseong-gu,
(2019-nCoV) Detection Kit Daejeon, South Korea

6 Standard M nCoV Real-time Detection Kit SD Biosensor, Inc.–C-4&5 Floor, 16, Deogyeong-daero
1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do,
16690, Republic of Korea

7 GENESIG® REAL-TIME PCR Primerdesign Ltd. – Unit 1, Watchmoor Point,

CORONAVIRUS (COVID-19) CE IVD KIT Watchmoor Road, Camberley, GU15 3AD, United
Kingdom

8 BDDS - CerTest - SARS-CoV2 BD MAX Certest Biotech, S.L -Zaragoza (spain)Certest Biotech,
assay (SEVERE ACUTE RESPIRATORY S.L. – Calle J N°1 POL. IND. RIO GALLEGO II-50840
SYNDROME-ASSOCIATED San Mateo De Gallego (Zaragoza), Spain
CORONAVIRUS IVDs [CT772])

9 BioFire COVID-19 TEST BioFire Defense, LLC. – 515 Colorow Drive, Salt Lake
City, Utah, 84108, USA

10 2019-nCov NUCLEIC ACID-BASED Sansure Biotech Inc. – No. 680, Lusong Road, Hi-
DIAGNOSTIC REAGENT KIT Tech Development Zone, Yuelu District, Changsha,
(FLOURESCENT PCR) Hunan Provice, 410205, People’s Republic of China

Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines

Trunk Line +63 2 857 1900 Fax +63 2 807 0751
Website: www.fda.gov.ph Email: info@fda.gov.ph
 Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION

NO. PRODUCT NAME MANUFACTURER

11 NUCLEIC ACID REAGENT TEST KITS Shanghai ZJ Bio-Tech Co., Ltd- – Floor 1, Building B,
FOR NOVEL CORONAVIRUS 2019-NCOV building 20, Floor 1, Building A, building 21, No. 528,
(FLUOROMETRIC PCR) Ruiqing Road, Zhangjiang high-tech Industry east district,
Shanghai, China

12 abTES™ COVID‐19 REAL‐TIME qPCR I AITbiotech Pte Ltd - 25 Pandan Crescent #05-15 TIC
KIT Tech Centre, Singapore

13 SARS-CoV-2 Fluorescent PCR Maccura Biotechnology Co., Ltd. – 16#, Baichuan Road,
High-Tech Zone, 611731 Chengdu, People’s Republic of
China

14 BGI Biotechnology (Wuhan) Co., Ltd. – Research and

REAL-TIME FLUORESCENT RT-PCR KIT Development Building B2, Wuhan National Bio-Industry
FOR DETECTING 2019-nCoV Base B, C, D Suite, No. 666, High-Technology Road,
Wuhan Donghu High-Technology Development Zone,
People’s Republic of China

15 TaqPath COVID-19 COMBO KIT Thermo Fisher Scientific, Inc. – 5781 Ban Allen Way,
Carlsbad, CA 92008, USA

16 ProTectTM COVID-19 RT-qPCR Kit (10024) JN Medsys Pte Ltd., -217 Henderson Road #02-08,
(10027) Singapore

17 cobas® SARS-CoV-2 MAT CODE: Roche Molecular Systems, Inc.- 4300 Hacienda Drive
09175431190 TO INCLUDE: cobas® SARS- Pleasanton, CA, USA
CoV-2 Control Kit P/N: 09175440190 AND
cobas® 6800/8800 Buffer Negative Control
Kit P/N: 07002238190

18 LOGIX SMART CORONAVIRUS DISEASE Co-Diagnostics, Inc. – 2401 S Foothill Dr. Suite D, Salt
2019 (COVID-19) KIT Lake City, UT 84109, USA

19 Abbott RealTime SARS-CoV-2 ASSAY Abbott Molecular, Inc– 1300 E. Touhy Avenue, Des
Plaines, IL 60018 USA

Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines

Trunk Line +63 2 857 1900 Fax +63 2 807 0751
Website: www.fda.gov.ph Email: info@fda.gov.ph
 Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION

NO. PRODUCT NAME MANUFACTURER

20 PowerChekTM 2019-nCoV Real-time PCR KogeneBiotech Co., Ltd- RM1101, C-dong, 168,
Kit Gasandigital 1-ro, Geumcheon-gu, Seoul, South Korea

21 BD SARS-CoV-2 REAGENTS for BD MAX Becton, Dickinson and Company -7 Loveton Circle
System Sparks, MD 21152, USA

22 Novel Coronavirus 2019-nCoV Nucleic Acid Sun Yat-Sen University Da An Gene Company Limited
Reagent Kit (Fluorescence PCR Detection) manufactured by: Guangzhou Hi-Tech Industry
Development Zone, No. 19, Xiang Shan Rd., Guangzhou,
China

23 NOVEL CORONAVIRUS (2019-NCOV) Shanghai Fosun Long March Medical Science Co., Ltd. –
NUCLEIC ACID DETECTION KIT 830 Chengyin Road, Baoshan District, People's Republic
(FLUORESCENCE PCR) of China

24 Smart Detect SARS-CoV-2 rRT-PCR Kit InBios International Inc. – 307 Westlake Ave North Suite
300, Seattle, WA 98109, United States

25 GeneFinder™ COVID-19 Plus Real Amp Kit OSANG Healthcare Co., Ltd – 132, Anyangcheondong-
ro, Dongan-gu, Anyang-si, Gyeonggi-do, 14040 Korea

26 Real-Time Fluorescent RT-PCR Kit for BGI Genomics Co. Ltd.-BGI Genomics Co. Ltd. – 250
Detecting SARS-2019 nCoV West 55th Street, New York, NY 10019 USA

27 PERKINELMER NEW CORONAVIRUS Suzhou Sym-Bio Lifescience Co. Ltd. - No. 115, North
NUCLEIC ACID DETECTION KIT Tai Ping Road, Taicang Economic Development Zone,
215400 Jiangsu Province, People's Republic of China

28 2019-nCoV NUCLEIC ACID TESTING KIT Wuhan Easydiagnosis Biomedicine Co., Ltd. – Room3,
(FLUORESCENCE PCR METHOD) Factory (3),1ST Floor, BLDG 25 Phase3.1 Wuhan Optics
Valley International Biopharmaceutical Enterprise
Accelerator, NO.388, Gaoxin 2nd Road East Lake HI-
Tech Development Zone, Wuhan, Hubei, China

29 MiRXES Fortitude Kit 2.0E (4480001) MiRXES Pte Ltd - 2 Tukang Innovation Grove JTC
MedTech Hub #08-01, Singapore

Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines

Trunk Line +63 2 857 1900 Fax +63 2 807 0751
Website: www.fda.gov.ph Email: info@fda.gov.ph
 Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION

NO. PRODUCT NAME MANUFACTURER

30 FOSUN COVID-19 RT-PCR DETECTION Fosun Pharma USA Inc.- 104 Carnegie Center, Suite 204-
KIT Princeton, NJ 08540, USA

31 REAL-Q 2019-nCoV DETECTION KIT Biosewoom Inc- 1F #102, 2F #204,205,206, 144,

Achasan-ro, Seongdong-gu, Seoul, 04783, Rep, of Korea

32 Primerdesign Ltd COVID-19 genesig Real- Primerdesign Ltd. – Unit 1, Watchmoor Point,
Time PCR assay Watchmoor Road, Camberley, GU15 3AD, United
Kingdom

33 QuantiVirus SARS-CoV-2 Test kit Diacarta, Inc. – 2600 Hilltop Drive, Richmond, CA
94806, USA

34 LabGun COVID-19 RT-PCR Kit Labgenomics Co., Ltd- #1204, 12F, 147, Gwanggyo-ro,
Yeongtong-gu, Suwon-si, Gyeonggi-do 16229, Republic
of Korea

35 FTD SARS-CoV-2 Fast Track Diagnostics Luxembourg S.à.r.l. – 29, rue

Henri Koch, L-4354 Esch-sur-Alzette, Luxembourg

36 Fosun COVID-19 RT-PCR Detection Kit Shanghai Fosun Long March Medical Science Co., Ltd. –
830 Chengyin Road, Baoshan District, People's Republic
of China

37 Novel Coronavirus (2019-nCoV) Nucleic Sansure Biotech Inc. – No.680, Lusong Road, Hi-Tech
Acid Diagnostic Kit (PCR-Fluorescence Development Zone, Yuelu District, Changsha, Hunan
Probing) Province, 410205, People’s Republic of China

38 1copy COVID-19 qPCR Multi Kit 1DROP INC. – A-203, Keumkang Penterium IT Tower 215,
Galmachi-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do, 13217,
Republic of Korea

39 DirectDetectTMSARS-CoV-2 Detection Kit Coyote Bioscience Co., Ltd – Room 509/510, 5F Chuangye
(PCR-Fluorescence Probe) (NL-CA002-2020- Zhong Road, #36 Haidan District, 100085, Beijing, China
49934)

Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines

Trunk Line +63 2 857 1900 Fax +63 2 807 0751
Website: www.fda.gov.ph Email: info@fda.gov.ph
 Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION

NO. PRODUCT NAME MANUFACTURER

40 iAMP-COVID 19 Detection Kit Atila BioSystems Inc- 740 Sierra Vista Ave, Mountain View,
CA 94043, United States

41 Lyra® Direct SARS-CoV-2 Assay Quidel Corporation-2005 East State Street, Suite 100 Athens,
OH 45701 USA

42 COVID-19 REAL-TIME PCR TEST CTK Biotech, Inc- 13855 Stowe Drive Poway, California
92064, USA

43 OPTI SARS-CoV-2 RT-PCR Test OPTI Medical Systems, Inc. – 235 Hembree Park Drive,
Roswell, Georgia 30076, USA

44 BioCore 2019-nCoV Real Time PCR Kit BioCore Co., Ltd. – Room 605 ACE Technotower 5th, 20,
Digital-ro 31-gil, Guro-gu, Seoul 08380, Republic of Korea

45 AQ-TOP COVID-19 Rapid Detection Kit Seasun Biomaterials, Inc.– N317, 11-3, Techno 1-ro, Yuseong-
gu, Daejeon, Korea

46 U-TOP COVID-19 Rapid Detection Kit Seasun Biomaterials, Inc.– N317, 11-3, Techno 1-ro, Yuseong-
gu, Daejeon, Korea

47 SARS-CoV-2 Test Kit Xiamen Zeesan Biotech Co., Ltd. – Building 1, No. 3701
Xiang'an North Road, Torch Hi - Tech Industrial
Development Zone (Xiang'an), Xiamen Fujian ,361101, China

48 Gnomegen COVID-19-RT-qPCR Detection Kit Gnomegen LLC. – 6440 Lusk Blvd Suite D207, San Diego,
CA, USA

49 Multiple Real-Time PCR Kit for Detection of Beijing Applied Biological Technologies Co., Ltd- Changping
2019-nCoV District 102206 Beijing P.R

50 virellaSARS-CoV-2 seqc real time RT-PCR Kit Gerbion GmbH & Co. KG-Remsstraße 1, 70806
2.0 Art.Nr. G 01128 Kornwestheim, Germany

51 MiRXES Fortitude Kit 2.1 (4480002) MiRXES Pte Ltd - 2 Tukang Innovation Grove JTC MedTech
Hub #08-01, Singapore

52 VereRTCoV™ SARS-CoV-2 Real-Time RT-PCR Veredus Laboratories Pte Ltd -83 Science Park Drive #04-02
2.0 (VRTC-CA200) Singapore

Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines

Trunk Line +63 2 857 1900 Fax +63 2 807 0751
Website: www.fda.gov.ph Email: info@fda.gov.ph
 Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION

NO. PRODUCT NAME MANUFACTURER

53 Radi Covid-19 Detection Kit KH Medical Co., Ltd. – C-1402,947, Hanam-daero, Hanam-si
Gyeonggi-do, Republic of Korea

54 EasyNat Diagnostic Kit for Novel-Coronavirus Ustar Biotechnologies (Hanghou) Co. Ltd – 3766 Nanhuan
(2019-nCoV) RNA (lsothermal Amplification- Road FI 8 Binjiang, Dist Hangzhou, Zhejiang 310053, China
Real Time Fluorescence Assay)

55 BioFire Respiratory Panel 2.1 (RP2.1) BioFire Defense, LLC. – 79 West 4500 South, Suite 14 Salt
Lake City, Utah 84107, USA

56 NOVEL CORONAVIRUS (2019-NCOV) RT- Dynamiker Biotechnology (Tianjin) Co., Ltd. – No. 14
PCR KIT Building, Eco-Business Park, 2018 Zhongtian Avenue, Sino-
Singapore Tianjin Eco-City, 300467 Tianjin, China

57 AccuPower® SARS-CoV-2 Real-Time RT-PCR BIONEER Corporation. – 8-11, Munpyeongseo-ro Daedeok-

Kit gu, Daejeon, 34302, Republic of Korea

58 GENAMPLIFY™ CORONA VIRUS DISEASE- MANILA HEALTHTEK INC.- 109 Brgy. Sta. Elena, Mayor
2019 (COVID - 19) rRT-PCR DETECTION KIT Gil Fernando Avenue, Marikina City
VERSION 2.0

59 PhoenixDx 2019-CoV Procomcure Biotech GmbH- Breitwies 1, 5303 Thalgau,

Austria

60 ®ARGENE® SARS-COV-2 R-GENE BioMérieux SA-376 Chemin de l'Orme, 69280 Marcy-l’Etoile -

France

61 GenePro SARS-CoV-2 Test Gencurix Inc.- #402, #908, #910, Digital-road 242, Goru-go,
Seoul, 08394, Republic of Korea

62 DiaPlexQ™ NOVEL CORONAVIRUS (2019- Solgent Co., Ltd-3F, 32, Techno 6-ro, Yuseong-gu, Daejeon,
nCoV) DETECTION KIT South Korea

63 COVID-19 (SARS-CoV-2) NUCLEIC ACID Wuhan EasyDiagnosis Biomedicine Co Ltd – Room 3 & 4 2nd
TEST KIT Flr Bldg 25, Phase 3.1 Wuhan Optics, Valley, International,
Biopharmaceutical Enterprise, Accelarator No 388 Gaoxin, 2nd
RD, East Lake Hi-Tech, Development Zone, Wuhan, Hubei,
430074, China

Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines

Trunk Line +63 2 857 1900 Fax +63 2 807 0751
Website: www.fda.gov.ph Email: info@fda.gov.ph
 Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION

NO. PRODUCT NAME MANUFACTURER

64 Qiastat-Dx Respiratory SARS-CoV-2 Panel QIAGEN GmbH – QIAGEN Strasse 1, D-40724 Hilden,
Germany

65 STANDARD M nCoV REAL TIME SD Biosensor, Inc.–C-4&5 Floor, 16, Deogyeong-daero

DETECTION KIT 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690,
Republic of Korea

66 Veri-Q PCR 316 Coronavirus disease Micobiomed Co., Ltd. – 3rd and 4th Floor, 54 Changeop-ro,
2019(COVID-19) – Detection Kit nCoV-QS Sujeong-gu, Seongnam-si, Gyeonggi-do, Republic of Korea

67 STAT-NAT® COVID-19 HK SENTINEL CH. S.p.A – Via Robert Koch, 2 20152, Milano,
Italy

68 Illumina COVIDSeq Test Illumina – 5200 Illumina Way, San Diego, California 92122
U.S.A

69 SARS-COV-2 Nucleic Acid Detection Kit (PCR- Zybio, Inc. – Floor 1 to Floor 4, Building 30, No.6 of Taikang
Fluorescent Probe Method) Road, Block C of Jianqiao Industrial Park, Dadukou District,
400082 Chongqing, China

70 ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 Vela Operations Singapore Pte. Ltd. – #05-07, The Kendall, 50
Science Park Road, Science Park II Singapore

71 COVID-19 Real-Time PCR Test CTK Biotech, Inc. – 13855 Stowe Dr. Poway California, USA

72 Kaira 2019-nCoV Detection Kit Optolane Technologies, Inc. – 6F, 20, Pangyoyeok-ro 241beon-
gil, Bundang-gu, Bundang-gu 13494 Seongnam-si, Gyeonggi-
do, Republic of Korea

73 Acu-Corona™ 2.0 Kit Acumen Research Laboratories Pte Ltd – 41 Science Park Road
#01-02, Singapore

74 Hymon SARS-CoV-2 Test Kit Hymonbio Co. LTD – 52 Yingang Rd., Bldg 4, TC-BIOBAY
Suzhou 215434 China

Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines

Trunk Line +63 2 857 1900 Fax +63 2 807 0751
Website: www.fda.gov.ph Email: info@fda.gov.ph
 Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION

75 DIAGNOSTIC KIT FOR NOVEL- Ustar Biotechnologies (Hangzhou) Co. Ltd – 3766 Nanhuan
CORONAVIRUS (2019-NCOV) RNA (PCR- Road FI 8 Binjiang, Dist Hangzhou, Zhejiang 310053, China
FLUORESCENT PROBE ASSAY)

76 COVID-19 RT-PCR Peptide Nucleic Acid (PNA) TNS Co., Ltd.– 5-6F, 19-12, Daehak-ro76beonan-gil, Yuseong-
kit gu, Daejeon, Korea

77 PerkinElmer® SARS-CoV-2 Real-time RT-PCR Suzhou Sym-Bio Lifescience Co. Ltd. - No. 115, North Tai
assay Ping Road, Taicang Economic Development Zone, 215400
Jiangsu Province, People's Republic of China

78 Bio-Rad SARS-CoV-2 ddPCR Test Bio-Rad Laboratories, Inc., – 5731 W. Las Positas Blvd.,
Pleasanton, CA, USA

79 Novel Coronavirus (2019-nCoV) Nucleic Acid Shanghai BioGerm Medical Technology Co., Ltd – Room
Diagnostic Kit (PCR-Fluorescence Probing) 1302-1307, 1309, Building 3, No. 1588 Huhang Highway,
Fengxian District, Shanghai, China

80 BioFire Respiratory Panel 2.1 Plus (RP2.1 Plus) BioFire Diagnostic, LLC. – 515 Colorow Drive, Salt Lake City,
Utah, 84108, USA

81 Novel Coronavirus (SARS-CoV-2) Fast Nucleic Jiangsu CoWin Biotech Co., Ltd. – No. 58 G52 Building, East
Acid Detection Kit (PCR-Fluorescence Probing) of Lujia Road, West Side of Tai Road, China Medical City,
Taizhou, Jiangsu, China
* Updated list in yellow highlights

Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines

Trunk Line +63 2 857 1900 Fax +63 2 807 0751
Website: www.fda.gov.ph Email: info@fda.gov.ph